Design, development, and evaluation of a registry system for hyperbaric oxygen therapy: A methodological study

Abstract Background and Aims Hyperbaric oxygen therapy (HBOT), utilizes 100% oxygen at pressures greater than sea‐level atmospheric pressure, for the treatment of conditions in which the tissues starve for oxygen. The Undersea and Hyperbaric Medical Society (UHMS) has granted HBOT approval for the treatment of various conditions. On the other hand, applying informatics registry systems can improve care delivery, ameliorate outcomes, and reduce the costs and medical errors for the patients receiving HBOT treatment. Therefore, we aimed to design, develop, and evaluate a registry system for patients undergoing HBOT. Methods In the first phase, the conceptual and logical models were designed after conducting symposiums with experts and having other experts review the models. In the second phase, the system was developed on the web using ASP.NET and C# programming languages frameworks. The last phase involved Nielsen's heuristic evaluation method for the system's usability. Five experts evaluated the system, including three health information management specialists and two medical informatics specialists. Results The hyperbaric patient information registry system (HPIRS) interacts with three types of users—a specialist physician, a nurse, and a system administrator. A scenario for each predefined activity was designed, and all the information was stored in the SQL servers. The five experts independently found 152 issues, of which 84 were duplicates. The 68 distinct issues of the system were then resolved. Conclusions The design and development of such registry systems can make data available and stored carefully to improve clinical care and medical research and decrease costs and errors. These registries can provide the healthcare systems with E‐health applications, improved data management, more secure data transfer, and support for statistical reporting. The implemented heuristic evaluation method can also provide a low‐cost and readily available system to fix the issues of the designed systems.

the second phase, the system was developed on the web using ASP.NET and C# programming languages frameworks. The last phase involved Nielsen's heuristic evaluation method for the system's usability. Five experts evaluated the system, including three health information management specialists and two medical informatics specialists.
Results: The hyperbaric patient information registry system (HPIRS) interacts with three types of users-a specialist physician, a nurse, and a system administrator. A scenario for each predefined activity was designed, and all the information was stored in the SQL servers. The five experts independently found 152 issues, of which 84 were duplicates. The 68 distinct issues of the system were then resolved.
Conclusions: The design and development of such registry systems can make data available and stored carefully to improve clinical care and medical research and decrease costs and errors. These registries can provide the healthcare systems with E-health applications, improved data management, more secure data transfer, and support for statistical reporting. The implemented heuristic evaluation method can also provide a low-cost and readily available system to fix the issues of the designed systems.

K E Y W O R D S
hyperbaric oxygen therapy, registry, registry systems, system development

| INTRODUCTION
The first report on the therapeutic use of hyperbaric oxygen therapy (HBOT) was released in 1879 by the French surgeon Fontaine, who believed that pressurized oxygen chambers can help with anesthesia. 1 Dr. Orville Cunningham also used HBOT and successfully treated a patient dying from the flu in 1918. 2 Later on, in the 1950s and 1960s, Churchill-Davidson and Boerma's work contributed to the recognition of the HBOT's effectiveness in the treatment of radiation therapy, anaerobic infections, carbon monoxide poisoning, and heart surgery. 3 In terms of mechanism; HBOT therapy places the patients in a monoplace chamber, designed for only one patient, or a multiplace chamber, that can fit more than two patients, where they are exposed to 100% oxygen at higher than 1.4 atmosphere absolute (ATA) pressures to inhale. HBOT subsequently increases plasma and tissue oxygen levels significantly, which would be much lower at normal atmospheric pressures. 4,5 The duration of treatment varies based on the specific symptoms but is usually between 1.5 and 2 h. 6,7 HBOT can exert a variety of effects. It inhibits neutrophil adhesion and chemotaxis, halts proinflammatory cytokines production, 8,9 increases arterial O 2 pressure, 10,11 alters the patient's microbiome metabolism, suppresses the formation of proinflammatory mediators, decreases circulating lymphocytes and leukocytes, 12 regulates the hypoxia response pathway, attenuates reperfusion injury, stimulates angiogenesis, assists with collagen matrix formation, promotes wound healing, 13 and maintains allograft durability. 14 Based on all the biochemical effects mentioned above, HBOT has been proven to be safe and effective either alone or as an adjunct method in treating various diseases, with few side effects. 15,16 According to the Undersea and Hyperbaric Medicine Society (UHMS), HBOT is approved for the following indications; carbon monoxide poisoning, crushing traumas, compartment syndrome, cyanide intoxication, gas gangrene, decompression sickness, compromised skin graft, central retinal artery occlusion, osteomyelitis, delayed radiation injury, necrotizing soft tissue infection, air or gas embolism, actinomycosis, acute thermal burns, sensorineural hearing loss, anemia, and diabetic wounds. 15 Possible adverse effects of HBOT are as follows: barotraumatic middle ear injury, sinus damage, oxygen poisoning-which can cause pulmonary failure, pulmonary fluid congestion, seizures or myopia-claustrophobia, hypoglycemia in diabetics, dizziness, and weakness. 17,18 Although, despite all the aforementioned therapeutic effects of HBOT, most of the available evidence regarding its efficiency is based on small-scale randomized clinical trials (RCTs), and retrospective studies. 19,20 In addition, there is controversy in regard to its efficacy and actual place as a treatment of choice for in some studies. 21 This controversy mostly stems from small-sampled published articles and the difficulties researchers face conducting large-sampled trials. Also, although many national-scale policy-making agencies like US Food and Drug Administration (FDA) have granted safety and efficacy approval to hyperbaric oxygen chambers for a wide range of conditions, 22 others like National Health Service (NHS) have only granted HBOT approval for decompression illness and gas embolism treatment. 23 Additionally, HBOT study and research have its own particular difficulties because; it is a long-standing treatment process with a daily session for a few months, and most centers do not have enough numbers of engaged cases to form a reasonable sample size and carry out a research study, and most patients are followed by other specialties so their outcomes are mostly unavailable. 6 Thus, to gather information regarding HBOT outcomes, long-term follow-up, and efficacy assessment a multicenter computerized data collection system is needed. One high-yield system is the registration system that is used in hospitals and clinics to record information about patients with specific conditions. The registry is the systematic data collection on specific diseases, such as cancer, and AIDS. [24][25][26] The database of this system contains uniform information about patients, collected systematically and comprehensively for scientific research and clinical services with a predefined policy. 27,28 This system is an ideal tool for clinical study when outcome assessment and treatment guideline policy making is essential. In many diseases, recording systems are used for epidemiological, preliminary, and risk modeling studies. 29 Therefore, we aimed to design, develop, and evaluate a registry system for patients undergoing HBOT to address the gaps in regard to its safety, efficacy, and outcomes.

| METHODS
This methodological study has three phases. Tehran University of Medical Sciences and Golestan hospital were the sites of the study. In the first phase: Conceptual and logical models of different parts of the information system of hyperbaric patients were developed by using the results of the first phase of the research and holding symposiums with specialists (8 physicians, 15 nurses, and 1 health information management). Objectives, mainstream events, preconditions processes, and background conditions were discussed in these symposiums. Then the system's conceptual model was designed in the form of Unified Modeling Language (UML) diagrams, including class diagrams, use case diagrams, and activity diagrams using Microsoft Visual software. Finally, the conceptual and logical models of the system were reviewed by experts, the corrective comments and suggestions were received, and the desired changes were applied.
In the second phase: We developed and implemented the development system of the Hyperbar Patient Information Registration System on the web using the ASP.NET Framework and in the C# programming language in the NET Framework 4.5 technology platform.
The SQL Server database was also used to store information.
In the third phase: The Nielsen evaluation method evaluated the system's usability. This evaluation includes 10 principles for examining user interface design problems and is performed by trained professionals to identify and eliminate defects and create effective interaction between the user and the system. This method evaluates a system based on design principles, including system status visibility, user control, compatibility, standards, flexibility, and efficiency. 30 In this study phase, three health information management specialists and two trained medical informatics specialists familiar with Nielsen's 10 evaluation principles were selected to independently examine the assessment of different parts of the hyperbaric patient information registration system in terms of 10 principles Nielsen.
After identifying the problems by each evaluator, duplicate cases were eliminated, and similar cases were identified. To evaluate the usability of the system, the Nielsen 10 Principles Checklist was used, which is usually used for exploratory evaluation. After evaluating the system by experts, problems were identified by each of them. The severity of the problem was then ranked from zero to four based on the Nielsen checklist. Finally, repetitive cases were eliminated and similar cases were identified. Data analysis was performed with SPSS version 21. Results are consulted with statistics and IT specialists (Table 1).

| Designing phase
The UML diagrams and Microsoft Visio were used to model the hyperbaric patient information registry system (HPIRS). The HPIRS interacts with three types of users-the specialist physician, the nurse, and the system administrator, and provides each of them with some features based on their defined roles and access levels ( Table 2 and Figure 1).
To determine the activities of the HPIRS, a scenario related to each activity was presented. Table 3 shows the scenario related to user registration in the HPIRS.

| Developing phase
Microsoft Windows was used to develop the HPIRS, and SQL Server was preferred to provide databases for data persistence. The architecture of the HPIRS is shown in Figure 2. To develop HPIRS, first, the programming language and its appropriate database were investigated. Because the system was web-based, the ASP.NET programming language was used. SQL Server was used to develop the database in Visual Studio infrastructure. The HPIRS is web-based and does not require software installation and so users can access the system through all browsers after specifying the username and confirming access. As shown in Table 4, among the identified issues, the most common ones were related to the item of "help and documentation" (19.11%) and "consistency and standards" (13.23%). The least problems were related to the item of "flexibility and efficiency of use" (4.41%) and "esthetic aspects and simple design" (4.41%). The primary purpose of information registration systems in healthcare centers is to record and compare patients' information and F I G U R E 1 Use case diagram for the hyperbaric patient information registry system user to be able to check and compare the condition of patients before and after using a treatment method. Creating the minimum set of data elements is one of the essential steps in developing any information system; It allows data from many organizations, institutions, and information systems to be matched to ease data comparison and determine the information needs of users. 32 Accuracy and completeness of data are the most critical factors affecting the quality and value of any registration system. 6,16,31,32 This system has three types of actors: a specialist physician, a nurse, and a system administrator, each with their own set of responsibilities. Data from various locations can be recorded at the same time using this user-friendly web-based registry system. It is both cheap and time intensive. It also makes it simple to update data and share it. 6 Some studies evaluate a web-based system designed in a Visual

| DISCUSSION
Studio environment with C# program language with NET 4.5 technology framework. The database was designed in SQL server 2016. Some other studies also used the mentioned software and programming language for creating and implementing their webbased system, which provided the necessary connection and integration between the server, programming, data access, and security tools. 25,33,34 T A B L E 3 The scenario for registration in the HPIRS

Use case name Register
Scenario Registration of the user into the system.

Brief description
Through this use case, the user enters and submits their identity information as well as a username and password.

Actors
Specialist physician, nurse, and system administrator.

Preconditions
Users must have been accepted by the system administrator before they were able to login to the system.

Postconditions
The user's identity information, username, and password are saved. S/he is registered into the system.

Workflow Actor System
− User runs the application. − User requests the registration form. − User enters identity information, username, and password. − User presses the "submit" button.
− The system displays the identity information form. − The system checks the entered information. − The system saves the user identity information. − The message "successfully registered" is shown.
Exceptions − If the user clicks the "back" button in any step, the system will exit without any changes. − If the system encounters a problem saving the information, it will display the message and will exit the form without any changes.
Abbreviation: HPIRS, hyperbaric patient information registry system. The results of other studies from Iran indicated that web-based logging systems increase the accuracy and speed of data entry and reduce the risk of errors along with lower cost; in addition, webbased registration systems facilitate updating information, creating complex reports, and sharing information. 35,36 An essential part of any system management is evaluation, which examines the performance of the system to assess the achievement Our study also focused on reviewing the design of the registry system, evaluating the development of the model and its different phases, and assessing the costs, issues, and problems of this system. Different programming languages, networks, and databases were implemented to evaluate and appraise the different aspects of this model. The present study has some benefits; its novelty is a critical strength and similar studies with a focus on HBOT are few. Also, evaluating and recognizing the most important problems of the hyperbaric registry systems is one of the essential study goals which is one of the practical aspects of our study.
But the study has some limitations; as this registry system is almost new, the data about this system is limited. As mentioned before, a checklist was used for the problems. But there may be some problems out of the checklist, this is another limitation of our study.
Also, we could not evaluate the system's effectiveness; this section needs more studies in the future. We also evaluated this system for a

ACKNOWLEDGMENTS
We thank all the participants for taking the time to contribute to the study. All authors have read and approved the final version of the manuscript and had full access to all of the data in this study and take complete responsibility for the integrity of the data and the accuracy of the data analysis. This study did not receive any specific grant from funding agencies in the public, or not-for-profit sectors.

CONFLICT OF INTEREST
The authors declare no conflict of interest.

TRANSPARENCY STATEMENT
The lead author (Esmaeil Mehraeen) affirms that this manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned (and, if relevant, registered) have been explained.

DATA AVAILABILITY STATEMENT
The authors confirm that the data supporting the findings of this study are available within the article [and/or] its Supporting Information.

ETHICS STATEMENT
The current study was extracted from the study project with code RLT-B 1514 entitled "Design, Development and assessment of Comprehensive Registry System for Submarine, Diving and Hyperbaric Medicine" conducted at Supreme National Defense University in 2021.